Cleared Traditional

SmartGrid

K163157 · Carestream Health · Radiology
Mar 2017
Decision
131d
Days
Class 2
Risk

About This 510(k) Submission

K163157 is an FDA 510(k) clearance for the SmartGrid, a Solid State X-ray Imager (flat Panel/digital Imager) (Class II — Special Controls, product code MQB), submitted by Carestream Health (Rochester, US). The FDA issued a Cleared decision on March 21, 2017, 131 days after receiving the submission on November 10, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number K163157 FDA.gov
FDA Decision Cleared SESE
Date Received November 10, 2016
Decision Date March 21, 2017
Days to Decision 131 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MQB — Solid State X-ray Imager (flat Panel/digital Imager)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1680

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